FDA 510(k) Decisions During August, 2003  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K032001 08/11/2003 POLY Q (GARANT L, PENTA M, PENTA H) 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K032070 08/27/2003 ELCACAM A-DEC, INC. TOM LOUISELL
K031331 08/12/2003 WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM ABBOTT VASCULAR INC. JOANNA KUSKOWSKI
K031759 08/04/2003 ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD ACON LABORATORIES, INC. EDWARD TUNG
K030898 08/27/2003 MOBILE BATTERY SERVICE STATION (MBSS) AD ELEKTRONIK GMBH RICHARD TOOTCHEN
K030429 08/18/2003 STERRAD 200 STERILIZER ADVANCED STERILIZATION PRODUCTS NATALIE BENNINGTON
K032198 08/20/2003 AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP AESCULAP, INC. MATTHEW M HULL
K030367 08/21/2003 COLUMBUS (PS) AESCULAP, INC. JOYCE KILROY
K030109 08/08/2003 ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. MOIRA BARTON
K014241 08/01/2003 COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D ALSIUS CORP. KEN COLLINS
K032448 08/22/2003 ALTATEC CERAMIC ABUTMENT ALTATEC BIOTECHNOLOGIES ROBERT SLOMOFF
K030222 08/19/2003 NX SYSTEM AMERICAN TELECARE, INC. PETE PLUCINAK
K021560 08/14/2003 MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS AMERIWATER BRAIN R BOWMAN
K032376 08/26/2003 ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K032069 08/27/2003 WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K031710 08/29/2003 OLYMPUS ULTRASONIC SURGICAL SYSTEM AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K032217 08/21/2003 14G CORMARK BIOPSY SITE IDENTIFIER ARTEMIS MEDICAL, INC. LINDA GUTHRIE
K032504 08/21/2003 ARTHROCARE SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K031694 08/29/2003 MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K013643 08/14/2003 AUSAM TOTAL ALBUMIN ASSAY AUSAM BIOTECTHNOLOGIES INC LYNN ROLAND
K031923 08/11/2003 ULTRASITE VALVE B. BRAUN MEDICAL, INC. SHERI L MUSGNUNG
K032261 08/22/2003 MODIFICATION TO TRELLIS RESERVE INFUSION SYSTEM (140CM CATHETER LENGTH, 10CM INFUSION LENGTH), TRELLIS RESERVE INFUSION BACCHUS VASCULAR, INC. GREGORY J MATHISON
K031566 08/19/2003 SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K031683 08/06/2003 TOX AMMONIA CALIBRATOR BAYER HEALTHCARE, LLC KENNETH T EDDS
K030407 08/19/2003 ADVISOR, MODEL 9200 BCI, INC. DONALD ALEXANDER
K031742 08/18/2003 BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER BCI, INC. DONALD J ALEXANDER
K032259 08/19/2003 PASCO MIC AND MIC/ID PANELS BD DIAGNOSTIC SYSTEMS LINDA K DILLON
K032162 08/08/2003 ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY BECKMAN COULTER, INC. LYNN WEIST
K032000 08/13/2003 COULTER LH 500 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. STAN SUGRUE
K032287 08/18/2003 MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 BECKMAN COULTER, INC. KIM WALKER
K032035 08/07/2003 SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI BECKMAN COULTER, INC. KIM WALKER
K032131 08/18/2003 BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO. MONICA E GIGUERE
K031943 08/06/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K031984 08/27/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K031851 08/01/2003 DENTISEPTIC HPC BETHEL, INC ERIC WADE
K032526 08/29/2003 BINDER CO2 INCUBATOR SERIE CB BINDER GMBH PAUL DISTLER
K023913 08/25/2003 NEUROTECH BAXOLVE TYPE 294 BIO-MEDICAL RESEARCH, LTD. MICHELLE SAWYER
K032017 08/08/2003 LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 BIO-RAD MARIA ZEBALLOS
K031043 08/27/2003 D-10 HEMOGLOBIN A1C BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K031427 08/19/2003 ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K032314 08/22/2003 VITEK 2 GRAM POSITIVE GATIFLOXACIN BIOMERIEUX, INC. NANCY WEAVER
K031865 08/13/2003 VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE BIOMERIEUX, INC. NANCY WEAVER
K031693 08/06/2003 MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA BIOMET, INC. PATRICIA S BERES
K030055 08/11/2003 MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K032396 08/21/2003 RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS BIOMET, INC. GARY BAKER
K032453 08/28/2003 ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL BIONOSTICS, INC. KATHLEEN STORRO
K030192 08/20/2003 DUET SYSTEM BIOVIEW LTD. ORLY MAOR
K032207 08/20/2003 COBRA COOLED SURGICAL PROBE, MODEL M004159670 BOSTON SCIENTIFIC CORP. APRIL I MALMBORG
K032183 08/01/2003 IQ HYDROPHILIC GUIDE WIRE BOSTON SCIENTIFIC CORP. ANNE V ROSSI
K032360 08/27/2003 MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT BOSTON SCIENTIFIC CORP. TODD KORNMANN
K032050 08/08/2003 PERIVAC KIT BOSTON SCIENTIFIC CORP. RONALD C ALLEN
K032375 08/19/2003 VAXCEL PORT, MODELS 45-336 AND 45-338 BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K031049 08/01/2003 GUGLIELMI DETACHABLE COIL (GDC) BOSTON SCIENTIFIC, TARGET ROXANE BAXTER
K031770 08/12/2003 CI TKR/UKR BRAINLAB, AG RAINER BIRKENBACH
K032057 08/21/2003 TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC BRANAN MEDICAL CORP. RAPHAEL WONG
K032325 08/28/2003 JOBST TRAVEL SOCKS BSN-JOBST, INC. ANGELO PEREIRA
K032432 08/28/2003 BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER BUSSE HOSPITAL DISPOSABLES, INC. JOSEPH M AZARY
K030277 08/06/2003 SOFT-CELL DUAL LUMEN CATHETERS C.R. BARD, INC. GLENN NORTON
K031749 08/21/2003 BODYGUARD INFUSION SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. GALI TZURY
K032142 08/08/2003 DATACAPTOR CAPSULE TECHNOLOGIE DANIEL KAMM
K032347 08/21/2003 BIOMARC TISSUE MARKER CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K030357 08/20/2003 QUANTIX/OR DEVICE CARDIOSONIX, LTD. AHAVA STEIN
K032068 08/22/2003 CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 CARDIOVENTION, INC. TESSA YAMUT
K031735 08/21/2003 CENTURION SES EPIKERATOME CIBA VISION CORPORATION PENNY NORTHCUTT
K031957 08/14/2003 MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K031921 08/25/2003 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K031577 08/06/2003 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K031752 08/05/2003 COLTOSOL F COLTENE/WHALEDENT INC. H.J. VOGELSTEIN
K031779 08/06/2003 CADSTREAM CONFIRMA, INC. PATRICIA A MILBANK
K031323 08/01/2003 DBT, DYNAMIC BUBBLE TRAP CONVERGENZA AG CHRISTIE DEWITT
K030441 08/29/2003 SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT COOK OB/GYN BRENDA DAVIS
K030742 08/29/2003 POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM CRYO VASCULAR SYSTEMS INC. KIM TOMPKINS
K030281 08/20/2003 CRYOTRON 2 CRYOTHERAPY DEVICE CRYONIC MEDICAL NORTH AMERICA SANDRA WILLIAMSON
K031651 08/13/2003 MODIFICATION TO CERASORB ORTHO CURASAN AG ROLF KAUFMANN
K032014 08/07/2003 N LATEX IGM DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K031636 08/11/2003 CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX DATASCOPE CORP. SUSAN MANDY
K024250 08/25/2003 MATCH PRESS PRESSABLE CERAMIC DAVIS SCHOTTLANDER & DAVIS, LTD. CLYDE E INGERSOLL
K031706 08/06/2003 CARDIOQ, MODEL 9051-7005 DELTEX MEDICAL LAWERENCE BROOKFIELD
K030977 08/25/2003 DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE DENTAURUM JAN W.A. DOORSCHODT
K030980 08/25/2003 DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE DENTAURUM JAN W.A. DOORSCHODT
K012681 08/22/2003 ANKYLOS DENTSPLY CERAMCO THOMAS B CAMERON
K031461 08/05/2003 CARRIER TIPS DENTSPLY INTL. P. JEFFREY LEHN
K032097 08/08/2003 DEPUY ACE VERSANAIL TIBIAL NAIL DEPUY ORTHOPAEDICS, INC. TIFFANI ROGERS
K030908 08/11/2003 DEROYAL SURGICAL DRAPES BACKTABLE COVER DEROYAL AUDREY DANIELS
K032283 08/20/2003 DESIGNS FOR VISION FIBEROPTIC LIGHT DESIGNS FOR VISION, INC. MARY MCNAMARA-CULLINANE
K030730 08/18/2003 FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT DIAGNOSTICS BIOCHEM CANADA, INC. G. R DUMONT
K031401 08/06/2003 FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. YAEL RUBIN
K031816 08/14/2003 DVNET MDV-PACS DVNET INTERNATIONAL TECHNOLOGY CO.,LTD. JEN KE-MIN
K031354 08/06/2003 EBI OMEGA21 SPINAL FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K032390 08/29/2003 MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM EBI, L.P. BARRY SANDS
K032500 08/25/2003 MODIFICARION TO WACKERS-LIU CQ SOFTWARE ECLIPSE SYSTEMS, INC. ROSINA ROBINSON
K032250 08/26/2003 GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 EDWARDS LIFESCIENCES, LLC. SUSAN REYNOLDS
K032026 08/27/2003 LCD MONITOR, RADIFORCE G11, G31, G51 EIZO NANAO CORPORATION KAY HAMAGUCHI
K032466 08/22/2003 SPIDERVIEW ELA MEDICAL, INC. SUSAN OLIVE
K032333 08/12/2003 CRYOCARE CS SURGICAL SYSTEM ENDOCARE, INC. EBEN GORDON
K032225 08/20/2003 EP-WORKMATE WITH RPM SYSTEM EP MEDSYSTEMS JAMES E KUHN
K023140 08/15/2003 VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 EPIMED INTERNATIONAL, INC. CHRISTOPHER B LAKE
K031778 08/07/2003 PRACTICEBUILDER 1-2-3 ERAD IMAGEMEDICAL CORP. GARY J ALLSEBROOK
K032121 08/13/2003 MODIFICATION TO E-SCAN XQ ESAOTE S.P.A. COLLEEN J DENSMORE
K032272 08/26/2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR EST INTERNATIONAL CORPORATION ELIZABETH DENG
K032236 08/26/2003 DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR EST INTERNATIONAL CORPORATION ELIZABETH DENG
K032339 08/08/2003 CARDIOVATIONS PORTABLE VIDEO SYSTEM ETHICON, INC. PETER CECCHINI
K032206 08/08/2003 PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION EV3 INC GLEN D SMYTHE
K030374 08/25/2003 SONIK LDI 20 AIR EVIT LABS, INC. S. DAVID PIPER
K023400 08/22/2003 FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT FCI OPHTHALMICS, INC. HILLARD W WELCH
K031830 08/05/2003 SAFEPRO PLUS SAFETY SYRINGE FORMOSA MEDICAL DEVICES, INC. JOSEPH J CHANG
K031674 08/14/2003 MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K032158 08/14/2003 XIVE DENTAL IMPLANT SYSTEM MULTIPLE FRIADENT GMBH CAROL PATTERSON
K032284 08/14/2003 XIVE TG DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K030639 08/12/2003 XIVE 3.0 DENTAL IMPLANT SYSTEM FRIANDENT GMBH CAROL PATTERSON
K031637 08/22/2003 INNOVA 3100 GE MEDICAL SYSTEMS LARRY KROGER
K031561 08/01/2003 CARDIOSOFT/CASE CARDIAC TESTING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DAVID WAHLIG
K032370 08/13/2003 CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES KAREN M LUNDE
K032252 08/21/2003 MODEL 120 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K032369 08/15/2003 MODIFICATION TO: APEXPRO TELEMETRY SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DIANA M THORSON
K032346 08/05/2003 UNITY NETWORK IS PATIENT VIEWER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DIANA M THORSON
K030574 08/21/2003 GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER GLUSTITCH, INC. DON BLACKLOCK
K030795 08/05/2003 LIFESYNE SYSTEMS GMP/COMPANIES, INC. RALPH JUGO
K031678 08/26/2003 HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP. BRUCE CERWIN
K032203 08/25/2003 HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 HEMOCUE, INC. R. J SLOMOFF
K020424 08/29/2003 V SET HENNIG ENTERPRISES EUROPE S.R.L. GEORGE O'NEIL
K031387 08/01/2003 ISOLETTE INFANT INCUBATOR, MODEL C2000E HILL-ROM MANUFACTURING, INC. MONICA FERRANTE
K032503 08/22/2003 EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K031432 08/07/2003 KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II HK SURGICAL, INC. SALLY M BOWDON
K023279 08/04/2003 GLUCOLEADER VALUE HMD BIOMEDICAL, INC. JEFFREY FLEISHMAN
K031435 08/04/2003 BONESOURCE BVF HOWMEDICA OSTEONICS DEBRA BING
K031702 08/08/2003 REFLEX ANTERIOR CERVICAL PLATE SYSTEM HOWMEDICA OSTEONICS KAREN ARIEMMA
K031730 08/29/2003 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS HOWMEDICA OSTEONICS CORP. DEBRA BING
K032244 08/08/2003 GAMMA 3 NAIL SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K032264 08/08/2003 MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K031744 08/08/2003 OMNIFIT HFX HIP STEM SERIES HOWMEDICA OSTEONICS CORP. DEBRA BING
K030369 08/08/2003 OPUS SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K032579 08/29/2003 S2 NAIL SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K031657 08/22/2003 STRYKER SPINE OASYS BONE SCREW HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K012715 08/01/2003 HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II HYGIA HEALTH SERVICES, INC. TRACY COMAS
K032254 08/29/2003 IBL C1Q-CIC CIA TEST IBL GMBH GARY LEHNUS
K031885 08/21/2003 NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K030596 08/08/2003 IMMUNICON CELLSAVE PRESERVATIVE TUBE IMMUNICON CORP. PETER SCOTT
K032282 08/21/2003 MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM IMPLEX CORP. MARCI HALEVI
K031462 08/06/2003 THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS IMPLEX CORP. MARCI HALEVI
K031106 08/12/2003 IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX IMTEC CORP. J. BRAD VANCE
K031712 08/28/2003 INION OTPS BIODEGRADABLE PIN INION LTD. HANNA MARTTILA
K030316 08/07/2003 AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) INOVISE MEDICAL, INC. KENDRA RATHKEY
K031639 08/22/2003 INTERMED ZOOM COLPOSCOPE INTERMED GROUP, INC. GEORGE GARAMY, JR.
K032095 08/08/2003 INTERPORE CROSS CEMENT RESTRICTOR INTERPORE CROSS INTL. PROSIE REY-FESSLER
K031692 08/22/2003 SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K031665 08/27/2003 IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS IRIDEX CORP. JOHN JOSSY
K031204 08/21/2003 DENTAPORT ZX J. MORITA USA, INC. KEITH A BARRITT
K030529 08/08/2003 LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE JDA (TIANJIN) PLASTIC RUBBER CO., LTD. CHEN YUHONG
K030479 08/18/2003 JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET JMS NORTH AMERICA CORP. SWEE CHEAU
K031544 08/07/2003 HEATER COOLER UNIT, MODEL HCU 30 JOSTRA AB LE ANN LATHAM
K030219 08/05/2003 DIGITAL TEMPERATURE MONITOR; MODEL KY-01 KANG YING MEDICAL APPLIANCES INC. CHING-CHU CHEN
K030237 08/29/2003 KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT KAPP SURGICAL INSTRUMENT, INC. ALBERT SANTILLI
K030693 08/27/2003 KENTEX DISPOSABLE VAGINAL SPECULUM KENTRON HEALTH CARE, INC. DR. SADARANGANI
K032041 08/27/2003 DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) LEMAITRE VASCULAR, INC. CARLOS CHAPARRO
K031282 08/05/2003 OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 LEMAITRE VASCULAR, INC. BRIAN K KEOGH
K031472 08/05/2003 ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS LIFESCAN, INC. FRANK PERALTA
K031994 08/21/2003 LINVATEC 300W XENON LIGHT SOURCE LINVATEC CORP. LAURA D KREJCI
K032298 08/26/2003 MODIFICATION TO OUTBACK CATHETER LUMEND, INC. MICHAEL A DANIEL
K032191 08/20/2003 OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM LUXSANO AB CONNIE HOY
K030440 08/26/2003 OASYS-ORAL AIRWAY SYSTEM MARK ABRAMSON, D.D.S., INC MARK ABRAMSON
K031866 08/14/2003 MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC MED-TEC,INC. DONALD F RIIBE
K032335 08/19/2003 MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K031442 08/13/2003 PBN GUIDEWIRES MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K030490 08/20/2003 ISM1+, IMS2+, AND UTM+ MEDICULT A/S RONALD G LEONARDI
K032329 08/06/2003 SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. A. ROBERT DEPALMA
K031483 08/01/2003 MEDRAD MANUAL SYRINGE LOADER MEDRAD, INC. ANDREW P ZELTWANGER
K023735 08/07/2003 LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001 MEDSYS, S.A. JEFF MORGAN
K022587 08/22/2003 MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K031917 08/19/2003 MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S MEDTRONIC MINIMED MIRIELLE MENGOTTO
K032005 08/22/2003 MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 MEDTRONIC MINIMED MIRIELLE MENGOTTO
K031700 08/29/2003 MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 MEDTRONIC PERFUSION SYSTEMS PREETI JAIN
K032265 08/11/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K031814 08/14/2003 STATCO2METER, MODEL 10-55372 MERCURY MEDICAL WAYNE GLOVER
K031532 08/01/2003 SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR METRO OPTICS OF AUSTIN, INC. DEANNA WERBER
K031600 08/13/2003 CONDUCTION CATHETER MICOR, INC. SUSAN FORGRAVE
K030586 08/27/2003 MICROPEAK MICRO DIRECT, INC. DAVID R STASZAK
K031992 08/07/2003 ECHELON MICRO CATHETER, MODEL 105-5091 MICRO THERAPEUTICS, INC. MARILYN R POURAZAR
K031852 08/20/2003 SAPPHIRE DETACHABLE FIBER COILS MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K023617 08/27/2003 DRI METHADONE METABOLITE ENZYME IMMUNOASSAY MICROGENICS CORP. LAKSHMI ANNE
K031958 08/15/2003 MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K031578 08/01/2003 MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR MICRUS CORP. MARGARET WEBBER
K030525 08/27/2003 CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES MID-ATLANTIC DIAGNOSTICS, INC. SUSAN J BUSH
K030957 08/20/2003 PERFECT CAPSULE MILVELLA PTY. LTD. JUDY F GORDON
K032078 08/25/2003 MITEK MICRO QUICKANCHOR MITEK WORLDWIDE SERGIO J GADALETA
K030860 08/22/2003 ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 MONOBIND JAY SINGH
K032090 08/21/2003 NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 MRI DEVICES CORP. TOM SCHUBERT
K032429 08/21/2003 QSC-127 SHOULDER ARRAY COIL SET MRI DEVICES CORP. THOMAS SCHUBERT
K030119 08/06/2003 NANMA ADJUSTABLE CONSTRICTION RING NANMA MFG CO., LTD. YOLANDA SMITH
K032301 08/21/2003 NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900 NEOGEN TECHNOLOGIES, INC LYDIA B BIGGIE
K031900 08/08/2003 HANDMASTER NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS JONATHAN KAHAN
K031954 08/21/2003 COOLTOUCH INCORPORATED MODEL"CT3" ND:YAG SURGICAL LASER SYSTEMS NEW STAR LASERS, INC. DONALD V JOHNSON
K031582 08/01/2003 WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 NIHON SEIMITSU SOKKI CO., LTD. DANIEL KAMM
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K032209 08/21/2003 NOMOS CORVUS 5.0M NOMOS CORP. FRANCIS X DOBSCHA
K031907 08/21/2003 NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 551 NORM PACIFIC AUTOMATION CORP. CHI-CHU WU CHEN
K030066 08/29/2003 CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 NUCLEAR ASSOCIATES CHRISTINE G CASTLEBERRY
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K031836 08/14/2003 PHILIPS FRESCO RELEASE 1 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN T HARMER
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K030381 08/27/2003 PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA PORTEX LTD. STEVE OGILVIE
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K032276 08/27/2003 CLICK HOLTER REMCO ITALIA S.P.A. LUIGI BUCCHI
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K024283 08/01/2003 CARDIODIRECT, MODELS 12M, 12I, 12S REYNOLDS MEDICAL LTD. GEORGE MYERS
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K032172 08/14/2003 DISPOSABLE POWDER FREE VINYL EXAM GLOVES SYNMERTEX CO, LTD ALBERT LING
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K021161 08/27/2003 TSO3 OZONE CHEMICAL INDICATOR TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC CHARLES O HANCOCK
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K021981 08/13/2003 IVENT 201 PORTABLE VENTILATOR VERSAMED LTD. KEN RAICHMAN
K031713 08/12/2003 AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS VIASYS HEALTHCARE, INC. GARY SYRING
K030517 08/01/2003 BALL RECORDING ELECTRODE/STIMULATION PROBE VIASYS HEALTHCARE, INC. GARY SYRING
K032483 08/22/2003 VIATRONIX V3D EXPLORER, REVISION 1.2 VIATRONIX, INC. MICHAEL MEISSNER
K031786 08/05/2003 TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM VISION-SCIENCES, INC. PAMELA PAPINEAU
K024359 08/08/2003 VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 VISTA SCIENTIFIC, LLC JONATHAN MODINE
K031748 08/27/2003 VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES VITALCARE GROUP, INC. MICHAEL MCAVENIA
K032047 08/06/2003 TRI-LOOP MICROWAVE ABLATION PROBE VIVANT MEDICAL, INC. STEVEN KIM
K031551 08/20/2003 NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) VYTERIS, INC. GEORGE M BASKINGER
K032073 08/13/2003 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. GORE & ASSOCIATES, INC. BRANDON HANSEN
K032168 08/15/2003 GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL W. L. GORE & ASSOCIATES, INC. BRANDON HANSEN
K031616 08/13/2003 IUR FLUID MANAGEMENT SYSTEM W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
K022721 08/26/2003 UROPOWER W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
K032228 08/11/2003 LORENZ 2.4 SELF DRILLING SCREWS WALTER LORENZ SURGICAL, INC. KIM REED
K031740 08/26/2003 VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES WELCH ALLYN PROTOCOL, INC. JAMES W SANDBERG
K031548 08/11/2003 LED HEADLIGHT WELCH ALLYN, INC. DAVID KLEMENTOWSKI
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K030384 08/12/2003 EVOLVE CERAMIC RADIAL HEAD IMPLANT WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE H REDDEN
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